mometasone inhaled (Rx)

Brand and Other Names:Asmanex Twisthaler, Asmanex HFA
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

powder for inhalation (Asmanex Twisthaler)

  • 110mcg/actuation
  • 220mcg/actuation

metered dose inhaler (Asmanex HFA)

  • 50mcg/actuation
  • 100mcg/actuation
  • 200mcg/actuation

Asthma

Indicated for maintenance treatment of asthma as prophylactic therapy

Asmanex Twisthaler

  • Received bronchodilators alone or inhaled corticosteroids: 220 mcg PO inhaled once daily in evening; may increase to 220 mcg q12hr if needed
  • Received PO corticosteroids: 440 mcg PO inhaled q12hr; not to exceed 880 mcg/day

Asmanex HFA

  • 2 inhalations PO q12hr (ie, 200-400 mcg q12hr); starting dose based on prior asthma therapy

  • Patients who are not on an inhaled corticosteroid: 200 mcg inhaled PO q12hr (as 2 actuations of 100 mcg/actuation)

  • Currently taking oral corticosteroids: 400 mcg inhaled PO q12hr (as 2 actuations of 200 mcg/actuation)

  • Failure to respond to initial dose after 2 weeks: Increasing dose may provide additional asthma control; maximum daily recommended dose is 200 mcg inhaled q12hr (as 2 actuations of 200 mcg/actuation); not to exceed 800 mcg/day

  • Maximum benefit may not be achieved for ≥1 week after beginning treatment; patients may experience a variable time to onset and degree of symptom relief

Dosing Considerations

Limitation of use

  • Not indicated for relief of acute bronchospasm

Dosage Forms & Strengths

powder for inhalation (Asmanex Twisthaler)

  • 110mcg/actuation
  • 220mcg/actuation

metered dose inhaler (Asmanex HFA)

  • 50mcg/actuation
  • 100mcg/actuation
  • 200mcg/actuation

Asthma

Indicated for maintenance treatment of asthma as prophylactic therapy

Asmanex Twisthaler

  • <4 years: Safety and efficacy not established
  • 4-11 years: 110 mcg PO inhaled once daily in evening; not to exceed 110 mcg/day
  • ≥12 years
    • Received bronchodilators alone or inhaled corticosteroids): 220 mcg PO inhaled once daily in evening; may increase to 220 mcg q12hr if needed

    • Received PO corticosteroids: 440 mcg PO inhaled q12hr; not to exceed 880 mcg/day

Asmanex HFA

  • <5 years: Safety and efficacy not established
  • 5 to <12 years: 100 mcg inhaled PO q12hr (as 2 actuations of 50 mcg/inhalation); not to exceed 200 mcg/day
  • ≥12 years
    • 2 inhalations PO q12hr (ie, 200-400 mcg q12hr); starting dose based on prior asthma therapy
    • Patients who are not on an inhaled corticosteroid: 200 mcg inhaled PO q12hr (as 2 actuations of 100 mcg/actuation)
    • Currently taking oral corticosteroids: 400 mcg inhaled PO q12hr (as 2 actuations of 200 mcg/actuation)
    • Failure to respond to initial dose after 2 weeks: Increasing dose may provide additional asthma control; maximum daily recommended dose is 200 mcg inhaled q12hr (as 2 actuations of 200 mcg/actuation); not to exceed 800 mcg/day
    • Maximum benefit may not be achieved for ≥1 week after beginning treatment; patients may experience a variable time to onset and degree of symptom relief

Dosing Considerations

Not indicated for relief of acute bronchospasm

Asmanex Twisthaler: Not indicated in children <4 years

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Interactions

Interaction Checker

and mometasone inhaled

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            All Interactions Sort By:
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            Adverse Effects

            >10%

            Headache (26%)

            Viral infection (14%)

            Pharyngitis (12%)

            Epistaxis (11%)

            1-10%

            Cough (7%)

            Upper respiratory tract infection (6%)

            Dysmenorrhea (5%)

            Frequency Not Defined

            Loss of taste

            Muscle soreness

            Vision blurred

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            Warnings

            Contraindications

            Hypersensitivity

            Immunosuppressed patients

            Tuberculosis

            Status asthmaticus or other acute asthma episode necessitating intensive measures

            Known hypersensitivity to milk proteins or any other ingredients

            Cautions

            Respiratory tract tuberculosis, untreated fungal or bacterial infections, viral or parasitic infections, ocular herpes simplex

            Nasal septum perforation, epistaxis, wheezing

            Cataracts, glaucoma, increased intraocular pressure reported; consider referral to an ophthalmologist in patients who develop ocular symptoms or long term therapy

            Risk of more serious or fatal course of chickenpox and measles in susceptible individuals; avoid use in unvaccinated or immunologically unexposed children or adults

            Deaths from adrenal insufficiency have occurred after abrupt withdrawal of oral steroids; taper withdrawal gradually

            May retard growth in children

            Immunocompromised patients

            Excessive use may suppress hypothalamic-pituitary-adrenal function

            During periods of stress or severe status asthmaticus, patient may require supplementary systemic corticosteroids immediately; carry warning card to that effect

            Long-term administration reduces bone mineral density

            Fungal infections

            • Localized infections of the mouth and pharynx with Candida albicans reported; if oropharyngeal candidiasis develops, treat with appropriate local or systemic (i.e., oral) antifungal therapy while remaining on treatment; at times therapy may need to be interrupted
            • To reduce risk of oropharyngeal candidiasis, after dosing, advise patients to rinse their mouth with water and spit out the contents without swallowing

            Drug interaction overview

            • Strong CYP3A4 inhibitors (eg, ritonavir): Use with caution; may cause increased systemic corticosteroid effects
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            Pregnancy & Lactation

            Pregnancy

            There are no randomized clinical studies in pregnant women

            Animal data

            • In animal reproduction studies with pregnant mice, rats, or rabbits, mometasone furoate caused increased fetal malformations and decreased fetal survival and growth following administration of doses that produced exposures ~1/3 to 8 times the maximum recommended human dose (MRHD) on a mcg/m2 or AUC basis
            • However, experience with oral corticosteroids suggests that rodents are more prone to teratogenic effects from corticosteroid exposure than humans

            Clinical considerations

            • In women with poorly or moderately controlled asthma, there is an increased risk of several perinatal adverse outcomes such as preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate
            • Closely monitor pregnant women with asthma and adjust medication as necessary to maintain optimal asthma control

            Lactation

            There are no available data on the presence in human milk, the effects on the breastfed child, or the effects on milk production

            Other inhaled corticosteroids, similar to mometasone furoate, are present in human milk

            Consider developmental and health benefits of breastfeeding along with the mother’s clinical need and any potential adverse effects on the breastfed infant from mometasone inhaled or from the underlying maternal condition

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Corticosteroid with potent anti-inflammatory properties; exerts effects on various cells, including mast cells and eosinophils; also exerts effects on inflammatory mediators (eg, histamine, eicosanoids, leukotrienes, cytokines)

            Absorption

            Minimally absorbed

            Onset: 1-3 days

            Bioavailability: <0.1%

            Distribution

            Protein bound: 98-99%

            Metabolism

            Metabolized in liver by CYP3A4

            Elimination

            Half-life: 5.8 hr

            Excretion: Urine, bile

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            Administration

            Oral Inhalation Administration

            Twisthaler

            • Hold the inhaler straight up (upright position) with the colored portion (the base) on the bottom; remove cap of Twisthaler while it is in this upright position to make sure that you get the right amount of medicine with each dose
            • Breathe out fully
            • Place the mouthpiece in mouth, holding it in a horizontal (on its side) position; firmly close lips around mouthpiece and inhale dose
            • Remove from your mouth and hold your breath for about 10 seconds, or as long as you comfortably can; do not breathe out into the inhaler

            HFA inhaler

            • Oral inhalation only
            • After each dose, rinse their mouth with water and, without swallowing, spit out the contents to help reduce the risk of oropharyngeal candidiasis
            • Remove cap from the mouthpiece of the actuator before use
            • Prime before using for the first time by releasing 4 test sprays into the air, away from the face, shaking well before each spray
            • In cases where the inhaler has not been used for more than 5 days, prime inhaler again by releasing 4 test sprays into the air, away from the face, shaking well before each spray
            • Do not use the mometasone HFA actuator with any other inhalation drug product.
            • Do not use actuators from other products with the Asmanex HFA canister

            Storage

            Twisthaler

            • Store in a dry place at 25ºC (77ºF); excursion between 15-30ºC (59-89ºF)

            HFA inhaler

            • Store at room temperature 20-25ºC (68-77ºF); excursions permitted to 15-30ºC (59-86ºF)
            • Keep out of reach of children
            • Do not use or store near heat or open flame; exposure to temperatures <120ºF may cause bursting; never throw container into fire or incinerator
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            Images

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.